Download Impella® Family of Products

Impella® Family of Products
(Currently available with FDA approvals/clearances)
Impella® 2.5
How the Impella 2.5 Works
The Impella 2.5 is a percutaneous, catheter-based heart
pump that pulls blood from the left ventricle through an
inlet area near the tip and expels blood from the catheter
into the ascending aorta.
The pump can be inserted via a standard catheterization
procedure (in the cath lab) through the femoral artery in
the leg, into the ascending aorta, across the valve and into
the left ventricle.
In June 2008, the Impella 2.5 received FDA 510(k)
clearance for partial circulatory support for periods up to 6
hours, for cardiac procedures not requiring cardiopulmonary bypass.
1. The pump is inserted through the femoral
artery into the ascending aorta.
3. Blood is pumped through an inlet
area in the left ventricle and expels
blood from the outlet area and into
the ascending aorta.
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2. The pump is then placed across the
valve and into the left ventricle
4. A 12 French motor, running at 50,000
revolutions per minute (RPM) enables the
Impella 2.5 to pump 2.5 liters of blood per
minute into the aorta and out to the rest of
the body.
Impella CP™
How the Impella CP Works
The Impella CP™ is a new percutaneous,
catheter-based Impella® device. The increased
flow of the Impella CP™ is delivered on the
same platform as the Impella 2.5.
The pump can be inserted through the same
procedure as the Impella 2.5.
In September 2012, the Impella CP received
FDA 510(k) clearance for circulatory support
for periods up to 6 hours, for cardiac
procedures not requiring cardiopulmonary
bypass.
Impella® 5.0
How the Impella 5.0 Works:
The Impella 5.0 catheter is an intravascular microaxial
blood pump that delivers up to 5.0 liters a minute of
forward blood flow from the left ventricle to the
aorta.
The Impella 5.0 can be inserted into the left ventricle
via femoral cut down or through the axillary artery.
The Impella 5.0 pump goes through the ascending
aorta, across the valve and into the left ventricle.
Micro-Axial Blood Pump
Delivers forward-flow from the left ventricle to the
aorta
 9 Fr catheter-based platform
 21 Fr micro-axial pump
 Minimal bedside support

Single Access Point
 Minimally invasive placement through a single
artery and into the left ventricle
 Several options for access site
 No septal puncture
 No priming/no blood outside the body
 Multiple large bore cannulae not required
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In April 2009, the Impella 5.0 received FDA 510(k)
clearance for circulatory support for periods up to 6
hours, for cardiac procedures not requiring
cardiopulmonary bypass.
Automated Impella® Controller (AIC)
The Automated Impella Controller (AIC) is the primary user
control interface for the Impella platform. The AIC controls
the Impella catheter performance, monitors for alarms,
and displays real time hemodynamic and catheter position
information. The AIC is approved for patients to be
transported while being supported by the Impella.
Automated Impella Controller Details:
 Large high resolution display delivers real time critical
care information
 Transportation capable with durable and secure cart
 Autoflow single touch activation
 Boost setting delivers maximum support
 Direct dial-in flow capability for weaning
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